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Last Updated: November 19, 2019

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CLINICAL TRIALS PROFILE FOR ONDANSETRON

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505(b)(2) Clinical Trials for Ondansetron

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00124787 A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis Completed Canadian Association of Emergency Physicians Phase 4 2005-04-01 Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
OTC NCT00124787 A Trial Comparing the Effect of Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis Completed St. Justine's Hospital Phase 4 2005-04-01 Dimenhydrinate, an over-the-counter, widely used drug in Canada, is an ethanolamine-derivative anti-histamine. It limits the stimulation of the vomiting center by the vestibular system, which is rich in histamine receptors. Multiple studies have shown its effectiveness in treatment of post-operative nausea and vomiting in children. It is also used for treatment of vertigo in children. Furthermore, it has the potential to be much more cost-effective than ondansetron, with an average cost of $0.90 US per dose . Its principal side effects are drowsiness, dizziness and anticholinergic symptoms. Restlessness and insomnia have also been described in children. To date, there has been no published data on the efficacy of dimenhydrinate in controlling emesis in children with acute gastroenteritis. RESEARCH QUESTION Do children treated with oral dimenhydrinate during acute gastro-enteritis experience less vomiting episodes than children treated with placebo?
OTC NCT01691690 Analgesic Effect of IV Acetaminophen in Tonsillectomies Active, not recruiting Nationwide Children's Hospital Phase 2 2012-10-01 Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses. Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid CB1 receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011). To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Ondansetron

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000289 Role of Metabolites in Nicotine Dependence (3) - 6 Completed University of Minnesota - Clinical and Translational Science Institute Phase 2 1998-05-01 The purpose of this study is to determine the effects of various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms.
NCT00000289 Role of Metabolites in Nicotine Dependence (3) - 6 Completed National Institute on Drug Abuse (NIDA) Phase 2 1998-05-01 The purpose of this study is to determine the effects of various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms.
NCT00000443 Ondansetron Treatment for Alcoholism Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 1969-12-31 The purpose of this study is to: a) evaluate the effectiveness of ondansetron (Zofran) in the treatment of alcohol dependent patients; b) investigate whether early versus late onset alcoholism predicts treatment outcome; and c) determine whether the early and late onset groups respond differently to treatment. Individuals will be "typed" into early onset and late onset alcoholism groups. Individuals will be randomly assigned to a 12-week outpatient treatment program.
NCT00004358 Phase II Study of Calcitonin for Tumoral Calcinosis Completed Ann & Robert H Lurie Children's Hospital of Chicago Phase 2 1992-11-01 OBJECTIVES: I. Determine whether intermittent, long-term, subcutaneous administration of calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact parathyroid hormone levels in patients with tumoral calcinosis. II. Determine whether calcitonin reduces or prevents tumor recurrence. III. Determine whether hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus. IV. Determine how repetitive calcitonin administration alters the biochemical markers of bone metabolism in osteopenic patients with tumoral calcinosis.
NCT00004358 Phase II Study of Calcitonin for Tumoral Calcinosis Completed National Center for Research Resources (NCRR) Phase 2 1992-11-01 OBJECTIVES: I. Determine whether intermittent, long-term, subcutaneous administration of calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact parathyroid hormone levels in patients with tumoral calcinosis. II. Determine whether calcitonin reduces or prevents tumor recurrence. III. Determine whether hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus. IV. Determine how repetitive calcitonin administration alters the biochemical markers of bone metabolism in osteopenic patients with tumoral calcinosis.
NCT00004767 Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders Completed Johns Hopkins University Phase 2 1985-01-01 OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ondansetron

Condition Name

Condition Name for Ondansetron
Intervention Trials
Postoperative Nausea and Vomiting 46
Nausea 34
Vomiting 32
Postoperative Pain 22
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Condition MeSH

Condition MeSH for Ondansetron
Intervention Trials
Vomiting 143
Nausea 117
Postoperative Nausea and Vomiting 70
Pain, Postoperative 44
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Clinical Trial Locations for Ondansetron

Trials by Country

Trials by Country for Ondansetron
Location Trials
United States 465
Canada 65
Italy 36
Germany 23
United Kingdom 21
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Trials by US State

Trials by US State for Ondansetron
Location Trials
Texas 55
California 30
New York 28
North Carolina 24
Ohio 21
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Clinical Trial Progress for Ondansetron

Clinical Trial Phase

Clinical Trial Phase for Ondansetron
Clinical Trial Phase Trials
Phase 4 120
Phase 3 65
Phase 2/Phase 3 9
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Clinical Trial Status

Clinical Trial Status for Ondansetron
Clinical Trial Phase Trials
Completed 209
Recruiting 91
Not yet recruiting 66
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Clinical Trial Sponsors for Ondansetron

Sponsor Name

Sponsor Name for Ondansetron
Sponsor Trials
Merck Sharp & Dohme Corp. 21
M.D. Anderson Cancer Center 18
GlaxoSmithKline 14
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Sponsor Type

Sponsor Type for Ondansetron
Sponsor Trials
Other 488
Industry 120
NIH 36
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